Before medicines, pharmaceuticals, agricultural chemicals, food additives and other chemicals are marketed, they are clinically tested for the safety of human bodies from carcinogenicity, toxicity, etc. Prior to the clinical tests, the safety is confirmed by means of non-clinical tests on animals such as rats and mice.
The non-clinical tests include a single dose toxicity test, a repeated dose toxicity test, a reproduction/generation toxicity test, and a mutagenicity test. The single dose toxicity test proves the amounts in which a chemical is toxic if it is given once in these amounts to an animal. This test also proves what characterizes the toxicity of the chemical. The repeated dose toxicity test proves the amounts in which a chemical is toxic if it is given two or more times in these amounts to an animal. This test also proves the amounts in which the chemical is nontoxic if it is given two or more times in these amounts to the animal. This test further proves what characterizes the toxicity of the chemical. The reproduction/generation toxicity test reveals the influences of a chemical on animal reproduction and generation. The mutagenicity test proves whether a chemical contains a substance that may cause a DNA lesion, and whether the chemical induces a mutation. The non-clinical tests also include a carcinogenicity test, a skin sensitization test, a skin photosensitization test and a dependence test.
Each of the non-clinical tests includes the steps of actually giving the animal the chemical, measuring the animal's body weight, food consumption, water consumption, urinary output, etc., observing the animal's clinical condition etc., making histopathological observations etc. about the animal, and accumulating, compiling or tabulating and analyzing the obtained data.
The non-clinical tests are conducted prior to the clinical tests, where the chemicals are actually given to human bodies. Since the chemicals eventually affect the human bodies, it is necessary to accurately understand and analyze the influences of the chemicals on living bodies. For this purpose, computer systems have been used to record, manage and analyze data (for example, Japanese Unexamined Patent Publication No. H07-110325).
As stated above, medicines, pharmaceuticals and other chemicals influence human bodies. This i s why the Health, Labor and Welfare Ministry and other Japanese government offices have set up strict standards of data management to prevent the foregoing safety test data from being altered dishonestly. The standards are known generally as GLP (good laboratory practice). As a matter of course, the computer systems that manage the data need to satisfy the GLP standards.
Needless to say, the design itself of the computer systems needs to meet the GLP standards. The application of the computer systems is very costly because the market for them is very niche, and because the application needs special know-how. When the computer systems are installed, it is necessary to confirm whether they work reliably in compliance with the GLP standards. After the system operation starts, the computer systems may be partially upgraded. In this case, it is necessary to confirm again that the whole systems work reliably in compliance with the GLP standards, and to record the confirmation in writing. It is also necessary to guarantee that the systems themselves have not been tampered with.
Each of the conventional computer systems is installed and operated with all functions integrated into it, and the whole system complies with the GLP and other standards. For this reason, even if a limited part of the system functions is upgraded, the whole system needs to be tested again for operation. For example, in recent years, because virus programs and other system destruction programs have been spreading through security holes, operation system makers have frequently been providing security patches. For safe system operation, it is essential that the computer systems be updated as soon as the security patches are provided.
As stated above, all functions are integrated into each of the conventional computer systems, and the whole system complies with the GLP and other standards. Consequently, even if a security patch is applied only to the operation system of the computer system, the whole computer system is regarded as upgraded and accordingly needs to be tested for validation. Validation usually takes two to three people three or more months. When the computer system is installed, it undergoes a general acceptance inspection. Once the computer system starts operating, however, it is practically impossible to carry out the subsequent validation required after the functions etc. of the system are updated. There is no real method of operation but continuing the system operation without updating and/or upgrading the computer system so that the validation can be avoided.
In the circumstances, even if a security hole is detected during the system operation, a security patch cannot be applied, but the system operation is continued with anxiety for system safety. The software itself of the computer system can be used with general purpose hardware. However, if the hardware operated as a general purpose computer, validation would be required by the updated operation system and the other updated applications that are not cooperative with the newly installed software. This substantially requires the provision of a special purpose computer, consequently making the installation cost very high.
Various conventional validation systems are disclosed (for example, Japanese Unexamined Patent Publication No. H10-275093). Because the validation systems are mainly used to find and correct bugs in programs under development, they detect even slight changes in the results of the validation and output N.G. (error) signals. If the validation systems are applied to the safety test support systems in operation, they may detect even slight changes of fonts and display color as bugs and/or alterations and output N.G. signals. Because these slight changes do not at all affect the operation of the support systems in compliance with the GLP and other standards, all the output N.G. signals need to be visually rechecked. Accordingly, although the validation is an automatic inspection, it actually requires substantial manpower.
The conventional computer system, into which all functions are integrated, has many functions that are seldom used. The addition of the useless functions raises the total cost of the system. When the computer system starts up, it authenticates the user. Thereafter, even if another person makes an entry into the computer system, the system is kept operating without further user authentication until it is terminated. Thus, it is essentially impossible to determine who has made the entry. This is a problem about the compliance with the GLP and other standards.